Candesartan Kern Pharma 4 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan Kern Pharma 4 mg Tablets EFG

Candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Candesartan Kern Pharma and what is it used for
2. What you need to know before you take Candesartan Kern Pharma
3. How to take Candesartan Kern Pharma
4. Possible side effects

5 Storage of Candesartan Kern Pharma

1. Contents of the pack and further information

1. What is Candesartan Kern Pharma and what is it used for

Your medicine is called Candesartan Kern Pharma. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients.
• treatment of adult patients with heart failure with reduced muscle function of the heart when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Candesartan Kern Pharma

Do not take Candesartan Kern Pharma

• if you are allergic to candesartan cilexetil or any of the other ingredients of Candesartan Kern Pharma (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the start of your pregnancy – see section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• if you have diabetes or kidney impairment and are being treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking Candesartan Kern Pharma.

Warnings and precautions

Before taking, or while taking Candesartan Kern Pharma, tell your doctor:

• if you have heart, liver or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting or have diarrhea.
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, think you may be pregnant or are planning to become pregnant, you must inform your doctor. It is not recommended to use candesartan at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancyas it may cause serious harm to your baby, see section Pregnancy.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

• if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Using Candesartan Kern Pharma with other medicines").

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Candesartan Kern Pharma”.

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan Kern Pharma on your own.

If you are going to have surgery, inform your doctor or dentist that you are taking Candesartan Kern Pharma. This is because candesartan, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

There is no experience with the use of candesartan in children (under 18 years). Therefore, candesartan should not be given to children.

Using Candesartan Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Candesartan may affect how some medicines work and some medicines may affect the effect of candesartan. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine elimination). Lithium (a medicine for mental health problems).

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Kern Pharma” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Using Candesartan Kern Pharma with food, drink, and alcohol

• You can take Candesartan Kern Pharma with or without food.
• When you are prescribed Candesartan Kern Pharma, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Candesartan before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another blood pressure lowering medicine instead. Candesartan should not be used at the start of pregnancy and in no case should it be administered from the third month of pregnancyas it may cause serious harm to your baby when administered from this time.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as it is not recommended to administer Candesartan to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartan Kern Pharma. If this happens to you, do not drive or use tools or machines.

Candesartan Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Candesartan Kern Pharma

Follow exactly the instructions of administration of Candesartan Kern Pharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts. It is important that you continue taking Candesartan Kern Pharma every day.

You can take Candesartan Kern Pharma with or without food.

Swallow the tablet with a little water.

Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The usual dose of Candesartan is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Heart failure:

• The usual initial dose of Candesartan is 4 mg once a day. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Kern Pharma than you should

If you have taken more Candesartan Kern Pharma than prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartan Kern Pharma

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan Kern Pharma

If you stop taking Candesartan Kern Pharma, your blood pressure may increase again. Therefore, do not stop taking Candesartan Kern Pharma before consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Candesartan Kern Pharma can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking Candesartan Kern Pharma and go to your doctor immediately if you have any of the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat
• swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing
• severe itching of the skin (with rash)

Candesartan Kern Pharma may cause a decrease in white blood cells. Your resistance to infections may decrease and you may feel tired, have an infection, or fever. If this happens, inform your doctor. Your doctor may perform a blood test from time to time to check that Candesartan Kern Pharma is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause dizziness or fainting.
• Changes in blood test results:
• • A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 user in 10,000)

• Swelling of the face, lips, tongue, and/or throat.
• A decrease in red or white blood cells. You may feel tired, have an infection, or fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of the flu.
• Nausea.
• Changes in blood test results:
• • A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.

• Cough.

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from the available data)

• Diarrhea.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Kern Pharma

• Keep out of the reach and sight of children.
• Do not use Candesartan Kern Pharma after the expiry date stated on the packaging or blister. The expiry date is the last day of the month indicated

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Candesartan Kern Pharma

• The active ingredient is candesartan cilexetil. Each tablet contains 4 mg of candesartan cilexetil.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, macrogol 8000, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose, and magnesium stearate.

Appearance and packaging of the product

Candesartan Kern Pharma 4 mg tablets are white, round, scored tablets with a K on one side. The tablet can be divided into two equal halves.

Candesartan Kern Pharma 4 mg tablets are available in packs of 14 tablets or 500 tablets (clinical packaging) in PVC/PVDC/Aluminum blisters.

Other presentations

Candesartan Kern Pharma 8 mg tablets EFG

Candesartan Kern Pharma 16 mg tablets EFG

Candesartan Kern Pharma 32 mg tablets EFG

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

This leaflet was last revised in February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es